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Monoclonal Antibodies

Targeted Therapies + Immunotherapy for Colorectal Cancer

Phase 1
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed adenocarcinoma originating from the colon or rectum
Metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 60 months
Awards & highlights

Study Summary

This trial is testing targeted therapies and immunotherapy as single agents or combinations for people with mCRC whose tumors are positive for certain biomarkers.

Who is the study for?
Adults with metastatic colorectal cancer who are in relatively good health (ECOG <=1) and have a life expectancy of at least 3 months. They must have biomarker-positive tumors as per specific arm definitions, measurable disease, and adequate organ function. Participants need to agree to use contraception and not be pregnant or breastfeeding. Those with severe medical conditions, active infections, uncontrolled pain or complications from prior treatments are excluded.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of various targeted therapies and immunotherapies—either alone or in combination—for metastatic colorectal cancer patients with certain biomarkers. These include Bevacizumab, Tiragolumab, Atezolizumab, Cetuximab among others along with chemotherapy regimens like FOLFOX and FOLFIRI.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to medications; issues affecting blood cells leading to increased infection risk; fatigue; liver problems; digestive disturbances such as nausea or diarrhea; skin reactions from drugs like Cetuximab; high blood pressure due to Bevacizumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is a type that started in the colon or rectum.
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My cancer has spread to other parts of my body.
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I am 18 years old or older.
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I have received treatments for cancer that has spread.
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I am fully active or can carry out light work.
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I agree to either not have sex or use birth control, and not donate sperm.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate
Secondary outcome measures
Disease Control Rate
Duration of Response
Percentage of Participants with Adverse Events (AEs)
+1 more

Trial Design

8Treatment groups
Experimental Treatment
Group I: Inavolisib + CetuximabExperimental Treatment2 Interventions
Participants will receive 9 milligrams (mg) of inavolisib by mouth once daily (QD) on Days 8-28 of Cycle 1, then QD on Days 1-28 from Cycle 2 onwards (1 cycle=28 days). Participants will also receive cetuximab intravenous (IV) infusion 400 mg/m2 body surface area on Day 1 of Cycle 1. All subsequent weekly (QW) doses will be 250 mg/m2 each.
Group II: Inavolisib + BevacizumabExperimental Treatment2 Interventions
Participants will receive 9 mg of inavolisib by mouth QD combined with bevacizumab 15 milligram/kilogram (mg/kg) IV once every three weeks (Q3W) on Day 1 of each cycle (1 cycle=21 days).
Group III: Divarasib + Cetuximab + FOLFOXExperimental Treatment3 Interventions
Participants will receive cetuximab IV 500 mg/m2 body surface area on Days 1 and 15 and FOLFOX on Days 1 and 15 with divarasib PO QD on Days 1-28. (Cycle length=28 days)
Group IV: Divarasib + Cetuximab + FOLFIRIExperimental Treatment3 Interventions
Participants will receive cetuximab IV 500 mg/m2 body surface area on Days 1 and 15 and FOLFIRI on Days 1 and 15 with divarasib PO QD on Days 1-28. (Cycle length=28 days)
Group V: Divarasib + CetuximabExperimental Treatment2 Interventions
Participants will receive cetuximab IV 500 mg/m2 body surface area on Days 1 and 15 with divarasib PO QD on Days 1-28. (Cycle length=28 days)
Group VI: Atezolizumab + Tiragolumab + BevacizumabExperimental Treatment3 Interventions
Participants in this randomized cohort will receive 1200 mg of atezolizumab by IV infusion on Day 1 of each cycle, combined with tiragolumab at a dose of 600 mg IV infusion on Day 1 of each cycle and bevacizumab IV infusion at a dose of 15 mg/kg on Day 1 of each cycle. (Cycle length=21 days)
Group VII: Atezolizumab + TiragolumabExperimental Treatment2 Interventions
Participants in this randomized cohort will receive 1200 mg of atezolizumab by IV infusion on Day 1 of each cycle combined with tiragolumab 600 mg IV infusion on Day 1 of each cycle. (Cycle length=21 days)
Group VIII: Atezolizumab + SY-5609Experimental Treatment2 Interventions
Participants will receive 1680 mg of atezolizumab by IV infusion on Day 1 of each cycle Q4W in repeated 28-day cycles combined with SY-5609 at a dose of 3, 4, 5, 6, 7 or 10 mg by mouth for 7 days, followed by 7 days off. (Cycle length=28 days) Open in the United States only. Enrollment is closed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Atezolizumab
2017
Completed Phase 3
~5860
Tiragolumab
2020
Completed Phase 2
~350
Cetuximab
2011
Completed Phase 3
~2480
SY-5609
2020
Completed Phase 1
~110
Inavolisib
2021
Completed Phase 2
~260
FOLFOX
2009
Completed Phase 3
~4560
FOLFIRI
2005
Completed Phase 3
~5860

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,431 Previous Clinical Trials
1,089,646 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,518 Total Patients Enrolled

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04929223 — Phase 1
Colorectal Cancer Research Study Groups: Inavolisib + Cetuximab, Inavolisib + Bevacizumab, Atezolizumab + Tiragolumab + Bevacizumab, Atezolizumab + Tiragolumab, Atezolizumab + SY-5609, Divarasib + Cetuximab + FOLFOX, Divarasib + Cetuximab, Divarasib + Cetuximab + FOLFIRI
Colorectal Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04929223 — Phase 1
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04929223 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this experimental trial still open?

"The investigation, posted on October 22nd 2021 and revised at the end of November 2022 is actively seeking participants. This information can be accessed through clinicaltrials.gov."

Answered by AI

What medical conditions are typically treated with Cetuximab?

"Cetuximab is a viable solution for treating recurrent platinum-resistant epithelial ovarian cancer, in addition to malignant neoplasms, recurrent primary peritoneal cancer with platin sensitivity and advanced non-squamous non-small cell lung cancer."

Answered by AI

Has the FDA granted authorization for Cetuximab to be used?

"Taking into account the fact that this is a Phase 1 trial - meaning there's limited information on its safety and efficacy - our team at Power assessed Cetuximab to be of low risk, rating it a score of one."

Answered by AI

Has Cetuximab been studied or implemented elsewhere?

"Cetuximab was initially researched in 2004 at Memorial Sloan Kettering Basking Ridge. Since then, the total number of completed clinical trials has climbed to 1,431; currently there are 720 active studies with a substantial portion taking place in Nashville, Tennessee."

Answered by AI

What are the geographical areas where this trial is being conducted?

"This clinical trial is seeking participants at Vanderbilt Uni Medical Center in Nashville, Tennessee, McGill University Health Centre in Montreal, Quebec and the Princess Margaret Cancer Center in Toronto. Additionally, 20 other sites are included as part of the study."

Answered by AI

What is the upper limit on enrollment for this experiment?

"To ensure the success of this trial, Hoffmann-La Roche needs to enlist 340 candidates that fit the predetermined enrollment criteria. In pursuit of this goal, they have established clinical sites at Vanderbilt Uni Medical Center in Nashville and McGill University Health Centre in Montreal."

Answered by AI

Who else is applying?

What state do they live in?
Nova Scotia
How old are they?
18 - 65
What site did they apply to?
Moffitt Cancer Center
Dana Farber Cancer Institute
Jewish General Hospital; Clinical Research Unit
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
2021. "A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04929223.
All > Colorectal Cancer Glendale
~147 spots leftby Sep 2025
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